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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
From 27 APR 1989 to 15 JUN 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.2 (Acute Toxicity (Inhalation))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
o-anisidine
EC Number:
201-963-1
EC Name:
o-anisidine
Cas Number:
90-04-0
Molecular formula:
C7H9NO
IUPAC Name:
2-methoxyaniline
Details on test material:
- Name of test material (as cited in study report): o-Anisidin D

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF-breed
- Age at study initiation: 8 to 10 weeks
- Weight at study initiation: males mean: 208 g; females mean: 197 g
- Housing: grouped (5 animals per cage) in macrolon cages (type 4) in fully airconditioned rooms
- Diet: rats diet Altromin1324 (Altromin GmbH, Lage/Lippe, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2
- Humidity (%): 50+/-20
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus:cylindrical plastic cage
- Exposure chamber volume: 60 L
- Method of holding animals in test chamber: each animal was in plastic tube
- Source and rate of air: laminar air stream of 800L/h at 4 bar from above
- Method of particle size determination: "Anderson-Kaskadenimpactor Mark III" of Anderson Samples Inc., Atlanta, USA
- Treatment of exhaust air: exhaust device at the basement of the exposure chamber in line with a diverse system of filters
- Temperature, humidity, pressure in air chamber: air control system of Hartman&Braun

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution:
at dose 2.17 mg/l: <0.6 µm to 7 µm
at dose 3.87mg/l: <0.6 µm to 4.8 µm
- MMAD (Mass median aerodynamic diameter):
at dose 2.17 mg/l: 1.71
at dose 3.87mg/l: 1.58
Analytical verification of test atmosphere concentrations:
yes
Remarks:
gas chromatography
Duration of exposure:
4 h
Concentrations:
2.17 and 3.87 mg/l (highest technically feasible exposure concentration)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: twice daily
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 3.87 mg/L air
Exp. duration:
4 h
Remarks on result:
other: higest technically feasible exposure concentration, no animals died during the 14 days observation period
Mortality:
- no deaths occured
Clinical signs:
other: - impairment of movement, respiration and reflexes were observed, as well as blood nasal discharge and cyanosis - all animals were free of clinical signs from day 8 after application
Body weight:
- body weight development in two female animals was impaired during the first week of the test. Nevertheless, they gained weight within the second week of the experiment.
- in all other animals body weight development was not impaired
Gross pathology:
- no macrosopically visible changes were found

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Exposure of male and female Wistar rats to the highest technically feasible concentration of 3.87 mg test item o-Anisidin D per L air for 4 hours did not result in the death of the animals during a 14 days observation period, resulting in a LC50 value of > 3.87mg/L air. The test results are adequate to fulfil the endpoint requirements.
Executive summary:

Acute inhalation toxicity of the test item o-Anisidin D has been investigated in male and female Wistar rats according to a standard acute method (OECD TG 403). They were exposed to 2.17 or 3.87 mg test substance per liter air for 4 h (maximal applicable dose). All animals survived the 14 days observation period. No macroscopic visible changes were observed at necropsy at the end of the observation period, resulting in a LC50 value of > 3.87 mg/L for the inhalation of aerosol.